NCT04475367

Brief Summary

Brief Summary: Through the App, the user will have the opportunity to connect directly with the health professional, clarify doubts and manage the treatment of their hypertension.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

May 29, 2020

Last Update Submit

July 18, 2020

Conditions

Keywords

softwarehypertensiontechnology

Outcome Measures

Primary Outcomes (1)

  • Blood pressure value

    systolic Blood pressure and dyastolic Blood pressure

    15 minutes

Secondary Outcomes (1)

  • Morisky scale

    15 minutes

Study Arms (2)

hypertensive patients using HyperCrossApp

EXPERIMENTAL

Interdisciplinary health care \+ HyperCross App

Other: App hypercross group

hypertensive patients without using HyperCrossApp

ACTIVE COMPARATOR

Interdisciplinary health care

Other: without App hypercross group

Interventions

hypertensive patients using HyperCrossApp

hypertensive patients using HyperCrossApp

Interdisciplinary health care

hypertensive patients without using HyperCrossApp

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypertensive patients admitted to the hypertension clinic at Instituto de Cardiologia
  • older 18 years

You may not qualify if:

  • Patients without a mobile phone compatible with the App

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tissue AdhesionsHypertension

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • Bruna Eibel, PhD

    Post Graduation professor - Cardiology Foundation

    STUDY DIRECTOR

Central Study Contacts

Ana Paula Reis, Nurse

CONTACT

Bruna Eibel, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
blind research assistant
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: The participants will be randomized into 2 intervention groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Specialist

Study Record Dates

First Submitted

May 29, 2020

First Posted

July 17, 2020

Study Start

July 10, 2020

Primary Completion

December 20, 2021

Study Completion

December 30, 2021

Last Updated

July 21, 2020

Record last verified: 2020-07